BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2022968 · Received February 24, 2011

    Report

    Report Number
    1644487-2011-00343
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 6, 2006
    Report Date
    January 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING MFR REVIEW OF A VNS PT'S PROGRAMMING HISTORY, IT WAS NOTED AN INTERRUPTED SYSTEMS DIAGNOSTICS TEST OCCURRED ON THE DAY OF INITIAL IMPLANT ((B)(6) 2006). THE PT LEFT THE OPERATING ROOM SET TO 1MA AND 60 MINUTES OFF TIME. THE CHANGE WAS NOT NOTED UNTIL (B)(6) 2006, WHERE THE SETTINGS WERE CHANGED BACK TO THE INTENDED PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR